EA-96-497 - Massachusetts General Hospital

January 27, 1997

EA 96-497

Ms. Maryanne Spicer, Director
Corporate Compliance
Massachusetts General Hospital
Fruit Street
Boston, Massachusetts 02114

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-01867/96-001; 030-00239/96-001; 030-08948/96-001; 070-01757/96-001)

Dear Ms. Spicer:

This refers to the NRC inspection conducted on November 19-22, 1996, at your facilities in Boston and Charlestown, Massachusetts. The purpose of the inspection was to determine whether activities authorized by the licenses were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with you and the members of your staff identified in the Inspection Report. During the inspection, an apparent violation of NRC requirements was identified, as described in the NRC inspection report transmitted with our letter, dated December 26, 1996. In the December 26, 1996 letter, the NRC provided you an opportunity to either respond in writing to the apparent violation addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violation in a letter to the NRC dated January 9, 1997.

Based on the information developed during the inspection and the information you provided in your January 9, 1997 response, as well as earlier letters provided on December 5 and December 20, 1996, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involves two examples of failure to secure licensed radioactive material or limit access to the material at the facilities. In one case, the inspectors found millicurie quantities of phosphorus-32, phosphorus-33, and sulfur-35 in unlocked refrigerators and freezers within the set of laboratories located on the south side of the fourth floor of Building 149 at the Charlestown Navy Yard facility, an unrestricted area, and at the time, access to the material was not limited and your staff did not control nor maintain constant surveillance of this ??licensed material. At the time, the security system for the building was deactivated, and the inspector had no difficulty gaining access to the laboratories. A similar finding was made by the inspectors on the 10th floor of the Wellman Building on the Hospital Campus in Boston, where the inspectors observed approximately 2 millicuries of phosphorus-32, 500 microcuries of sulfur-35, and 250 microcuries of carbon-14 in posted but unlocked refrigerators and freezers.

This violation represents a significant regulatory concern because the failure to maintain appropriate security of material could result in the material being lost or stolen, and also has the potential to cause exposures to members of your staff as well as members of the public. The NRC is also concerned that your Radiation Safety Office staff has rarely identified security as a problem during their periodic audits of the research areas, and this may be due to the fact that their audits have only been performed during normal working hours when sufficient research staff is present in the areas. The particular findings by the NRC inspectors were made during the early morning hours at the facilities, when your security systems had already been deactivated for the day. The violation is classified in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions, which were described in your January 9, 1997, as well as in previous letters submitted on December 5 and 20, 1996, included, but were not limited to: (1) formation of a task group on December 3, 1996, to examine interim security measures from the affected locations, and conduct audits of areas where radioactive materials are located; (2) changing the time for deactivation of the security system from 6 a.m. to 10 a.m. when more personnel are available; and (3) informing all users on November 22 and December 5, 1996, of the importance of security of material.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you may make reference, as appropriate, to your earlier submittals to the NRC. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).

Sincerely,

Original signed by Hubert J. Miller Regional Administrator

Docket Nos.: 030-01867; 030-00239; 030-08948; 070-01757
License Nos.: 20-03814-80; 20-03814-14; 20-03814-81; SNM-1490

Enclosure: Notice of Violation

cc w/encl:
Rex Woodleigh, Radiation Safety Officer
Commonwealth of Massachusetts

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NOTICE OF VIOLATION

Massachusetts General Hospital Boston, Massachusetts

Docket Nos: 030-01867; 030-00239; 030-08948; 070-01757 License Nos: 20-03814-80; 20-03814-14; 20-03814-81; SNM-1490 EA 96-497

During an NRC inspection conducted on November 19-22, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy) NUREG-1600, the violations are listed below:

10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above,

1. at 7:00 a.m. on November 21, 1996, the licensee did not secure from unauthorized removal or limit access to licensed material stored in the set of laboratories located on the south side of the fourth floor of Building 149 at the Charlestown Navy Yard facility, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, at that time, an NRC inspector observed 6 millicuries of phosphorus-32, 2 millicuries of phosphorus-33, and 1 millicurie of sulfur-35 in posted but unlocked refrigerators and freezers, and because the security system was deactivated, the inspector had no difficulty gaining access to the laboratory. The one researcher who was present in the laboratory did not challenge the inspector.

2. at 6:45 a.m. on November 22, 1996, the licensee did not secure from unauthorized removal or limit access to licensed material stored on the 10th floor of the Wellman Building on the Hospital Campus in Boston, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, at that time, the NRC inspector, while touring the building, observed approximately 2 millicuries of phosphorus-32, 500 microcuries of sulfur-35, and 250 microcuries of carbon-14 in posted but unlocked refrigerators and freezers, and at the time, the inspectors found no one present in the area, and the security system was deactivated. (01013)

This is a Severity Level III violation (Supplements IV and VI).

Pursuant to the provisions of 10 CFR 2.201, Massachusetts General Hospital is required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in the Notice, an order or Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, or proprietary, information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information).

Dated at King of Prussia, Pennsylvania
this 27th day of January 1997